Kornimate/medical-research-clean huggingface dataset:
analgesia for 2nd trimester termination of pregnancy

Conditions: Pain

Summary: there has been very little investigation into the management of pain from 2nd trimester termination of pregnancy or unexpected fetal loss. the standard of practice in north america is usually intravenous patient controlled analgesia (iv pca), using a narcotic wuch as fentanyl. the goal of this study is to compare the quality of recovery after termination of pregnancy using fentanyl iv pca or patient controlled epidural analgesia (pcea), a standard of care for live births. the study will be conducted as a randomized controlled trial.

epidural analgesia is known to provide superior analgesia for labour with minimal maternal and fetal side effects. this mode of analgesia is not usually offered to patients who require termination of their pregnancies or who suffer unexpected fetal losses, although they go through labour and delivery with likely more difficult psychological circumstances. we plan to compare patient controlled epidural analgesia (pcea) with intravenous patient controlled analgesia (iv pca), for 2nd trimester terminations of pregnancy. we hypothesize that pcea provides better quality of recovery than iv pca. the previously validated quality of recovery - 40 questionnaire will be used to measure a patient's quality of recovery. the results of this study will determine the optimal method of pain relief for late termination of pregnancy or fetal loss.

Eligibility criteria:
inclusion criteria: * interruption of pregnancy between 12 and 23 6/7 weeks exclusion criteria: * documented allergy to fentanyl or bupivacaine * coagulopathy * drug or narcotic abuse * contraindication to neuraxial analgesia * inability to comply with ivpca or pcea * inability to complete the qor-40 questionnaire * top due to maternal problems

Keywords: termination of pregnancy epidural iv pca
evaluation of cross-linked polyelectrolyte (clp) with placebo in heart failure subjects

Conditions: Heart Failure

Summary: this is a placebo-controlled study to determine the effect of clp in heart failure subjects with fluid overload.


Eligibility criteria:
selected inclusion criteria: * age 21 years or older at randomization * heart failure with at least one of the following signs of current fluid overload: 1. peripheral (or sacral) edema \>1+ or ascites during screening or on day of randomization 2. pulmonary congestion as determined by chest x-ray during the screening period * ambulatory and able to perform the 6-minute walk test selected exclusion criteria: * participation in another clinical trial of an investigational or marketed drug within 30 days or 5 half-lives (whichever is longer) preceding screening * any hospitalization or unscheduled outpatient decongestion therapy using iv diuretics, ultrafiltration, or paracentesis within 8 weeks prior to or during screening * coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 2 months prior to or during screening or anticipated need during study participation * heart transplant recipient, or anticipated need for transplant or lvad during study participation * any of the following events having occurred within 8 weeks prior to or during screening: myocardial infarction, transient ischemic attack, stroke, or acute coronary syndrome as judged by the investigator
evaluation of the risk for radiographic and clinical nonunion in patients with previous bisphosphonates therapy.

Conditions: Non-union or Delayed Healing Fractures

Summary: dose and duration of bisphosphonate therapy will increase the likelihood that patients experience delayed healing of non-union fractures.

we intend to review the uwhealth patient database to identify individuals with delayed or nonunion fractures. subsequently, we will collect associated medical information related to fractures such as age of osteoporosis diagnosis, bmi, previous bisphosphonate treatment, type and location of fracture, time to complete union, other treatment needed for nonunion etc. with this information, we will evaluate the risk of delayed and nonunion fractures in patients previously receiving bisphosphonate treatment compared to a normal population. we also will investigate other potential causes of delayed or nonunion fractures in this population.

Eligibility criteria:
inclusion criteria: * men and women older than 60 years old with delayed or nonunion low trauma fracture between 01/01/2000 - 12/31/2011. exclusion criteria: * none

Keywords: osteoporosis, low trauma fracture, non-union fracture, delayed healing fracture, bisphosphonate
efficacy and safety of two doses of hipnos in the treatment of adults with insomnia

Conditions: Insomnia

Summary: the purpose of this study is to evaluate the efficacy and safety of three doses of hipnos medication in adults with insomnia.


Eligibility criteria:
inclusion criteria: * participants aged 50 years or more; * diagnosis of insomnia disorder according to criteria defined by the dsm-v; * sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit. exclusion criteria: * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * known hypersensitivity to the formula components used during the clinical trial; * decompensated diabetes mellitus, hypothyroidism or hyperthyroidism; * history of hepatic impairment; * current smoking; * pregnancy or risk of pregnancy and lactating patients; * history of sleep-disordered breathing, sleep disorders associated with changes in circadian rhythm and severe neurological and psychiatric disorders; * diagnosis of clinical diseases that interfere with sleep; * participants who have used psychostimulant medications, antidepressants and/ or antipsychotic with sedative effects and/or antiepileptic; * participation in clinical trial in the year prior to this study.

Keywords: insomnia
teriflunomide plus high-dose dexamethasone as first-line treatment in newly diagnosed primary immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: a randomized, open-label, multicenter study to compare the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (itp).

this is a parallel-group, multicenter, randomized controlled trial of 132 adults with itp in china. patients were randomized to teriflunomide plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. patients who do not respond to dexamethasone may receive another cycle of high-dose dexamethasone therapy within 2 weeks. platelet count, bleeding, and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed, treatment naïve itp patients 2. patients with a platelet count \<30,000/μl or a platelet count \<50,000/μl with bleeding manifestations at the enrollment; 3. willing and able to sign written informed consent. exclusion criteria: 1. received first-line and second-line itp-modifying therapy (any previous dose of corticosteroids or other immune-suppressive agents); 2. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit; 3. active or a history of malignancy; 4. positive test result for hepatitis b virus (hbv), hepatitis c virus (hcv), or human immunodeficiency virus (hiv); 5. pregnancy or lactation; 6. pre-existing acute or chronic liver disease, or serum alanine aminotransferase (alt) greater than 2 times the upper limit of normal (uln); 7. current or recent (\<4 weeks before screening) clinically serious viral, bacterial, fungal, or parasitic infection; 8. a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test; 9. patients who are deemed unsuitable for the study by the investigator.

Keywords: teriflunomide dexamethasone
robotic assisted transanal total mesorectal excision surgery for rectal cancer in low site

Conditions: Rectal Neoplasms

Summary: to investigates the feasibility, practicability, safety and subjective as well as functional outcome of robotic transanal total mesentery excision for rectal cancer in low site.

transanal total mesorectal excision (tatme) may offer a better way to achieve radical resection and functional protection for lower rectal cancer, which have been regarded as challenging situations in rectal cancer surgery. however, the narrow angle and limited space of the operation restrict the wide spread of this technique. da vinci robotic system has achieved good results in rectal cancer surgery. robotics may help to overcome technical difficulties in tatme. the purpose of this study was to explore the availability of da vinci robotic-assisted transanal total mesorectal excision(r-tatme) this study investigates the feasibility, practicability, safety and subjective as well as functional outcome of robotic transanal total mesentery excision for rectal cancer in low site.

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the rectum by biopsy * the lower edge of the tumor from the anal margin less than 8cm according to mri or rigid endoscopy * tumor diameter less than 4cm * baseline clinical stage i-iii: ct1-3 n0-2 m0 (ajcc v7) * tolerable to surgery * be able to understand and willing to participate in this trial with signature exclusion criteria: * history of malignant colorectal neoplasia * recent diagnosis with other malignancies * patients requiring emergency surgery such as obstruction，perforation and bleeding * tumor involving adjacent organs, anal sphincter, or levator ani muscle muti-focal colorectal cancer * preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence history of inflammatory bowel disease or familial adenomatous polyposis * participating in other clinical trails * history of pelvic radiation * bmi \> 40 * large uterine fibroids * can not tolerate the surgery * history of serious mental illness * pregnancy or lactating women * preoperative uncontrolled infection * the researchers believe the patients should not enrolled in

Keywords: transanal surgery robotic surgery total mesorectal excision
study evaluating the safety and ability to produce immune response of prevenar and meningitec given at the same time

Conditions: Healthy

Summary: the purpose of this study is to evaluate the safety and immunogenicity of concomitant prevenar and meningitec compared to prevenar alone and meningitec alone when used as part of the routine vaccination series in healthy infants


Eligibility criteria:
inclusion criteria: * healthy infants aged 6 to 9 weeks

Keywords: meningococcal disease pneumococcal disease meningitis
a study of evacetrapib (ly2484595) in japanese participants with primary hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the main purpose of this study is to evaluate the efficacy and safety of the study drug known as evacetrapib in japanese participants with primary hypercholesterolemia. the double blind treatment period will last for 12 weeks and the open-label extension period will last for an additional 40 weeks.


Eligibility criteria:
inclusion criteria: * japanese outpatients who are diagnosed with primary hypercholesterolemia with ldl-c levels (measured by a direct method at baseline) that meet the following criteria. (participant categories are based on the definition in japan atherosclerosis society 2012 guidelines.) * category i: 160 mg/deciliter (dl)≤ldl-c\<200 mg/dl * category ii: 140 mg/dl≤ldl-c\<175 mg/dl * category iii: 120 mg/dl≤ldl-c\<150 mg/dl * have triglycerides (tg) ≤400 mg/dl. * have hdl-c \<100 mg/dl. exclusion criteria: * participants on ldl apheresis or plasma apheresis. * participants with secondary hypercholesterolemia or familial hypercholesterolemia. * any planned angiography. if angiography is planned, participants may be screened and enrolled after all such planned procedures are completed. * history of any of the following any conditions: * stable angina or acute coronary syndrome (unstable angina, myocardial infarction), old myocardial infarction or a coronary revascularization procedure including stent placement, or symptomatic carotid artery disease * peripheral arterial disease * ischemic stroke or transient ischemic attack (tia) * intracranial hemorrhage * abdominal aortic aneurysm * have systolic blood pressure (sbp) \>160 millimeters of mercury (mm hg) or diastolic blood pressure (dbp) \>100 mm hg. * have a hemoglobin a1c ≥8.4% (national glycohemoglobin standardization program). * during the study period, participants who plan to use, are likely to require, or unwilling or unable to stop with adequate washout any prescription, over the counter medication, supplements or health foods with the intent to treat serum lipids (ldl-c, hdl-c, tg) including but not limited to these classes of drugs: statin, ezetimibe, bile acid sequestrant, eicosapentaenoic acid (epa) and docosahexaenoic acid (dha). participants taking probucol, fibrate or nicotinic agents within 8 weeks before screening are excluded from the study. * have been exposed to cholesteryl ester transfer protein inhibitors (e.g., anacetrapib or dalcetrapib).
comparison of therapeutic efficacy between intralesional bleomycin and cryotherapy in plantar warts

Conditions: Viral Wart

Summary: a randomized control trial to compare the efficacy difference between intralesional bleomycin and cryotherapy in treating plantar warts.

in spite of many available studies on bleomycin and cryotherapy in treating warts, little head-to-head research is carried out to compare the efficacy of these treatments. this study shows clear difference in the clearance of warts treated with intralesional bleomycin and cryotherapy.

Eligibility criteria:
inclusion criteria -healthy individuals of both genders between 18 to 50 years exclusion criteria * pregnant and lactating women * history of vascular diseases/ chilblains * immunocompromised patients * treated previously for warts
micronet covered stent in in arterial locations beyond the carotid bifurcation - flow-guard study

Conditions: Peripheral Vascular Diseases

Summary: prospective observational study of micronet covered stent implantation in the elevated risk peripheral lesions (high lesion load, thrombus containing, highly calcified). open-label, non randomized, single arm observational study. jagiellonian university medical college research project.

peripheral artery stents in routine use (both balloon expandable and self-expendable) do not sufficiently prevent distal embolization. they might induce a "cheese-grater" effect - a consequence of their single layer design with uncovered space between stent struts. aim of the study is to evaluate short and long term safety and efficacy of micronet covered stent implantation in the high risk lesions beyond the carotid bifurcation. treatment eligibility will be evaluated by a vascular team process (angiologist, vascular surgeon, cardiologist). optimal pharmacotherapy will be administered according to the current guidelines. symptomatic and asymptomatic patients with peripheral artery disease requiring endovascular treatment for high risk stenosis (soft plaque, highly calcific plaque) per vascular team assessment. a group of 30-50 consecutive patients meeting inclusion and exclusion criteria will be enrolled.

Eligibility criteria:
general inclusion criteria: * patients older than 18 years, eligible for peripheral artery stenting after vascular team evaluation, according to local standards * written, informed consent to participate * agreement to attend protocol required (standard) follow up visits and examinations exclusion criteria: * life expectancy \<1 year (e.g. active neoplastic disease). * chronic kidney disease with creatinine \> 3.0 mg/dl. * myocardial infarction in 72 hours proceeding the stenting procedure (if possible, postponing the procedure) * pregnancy (positive pregnancy test) * coagulopathy. * history of uncontrolled contrast media intolerance angiographic inclusion criteria: * de novo lesion in major arteries or grafts connecting arteries * stenosis eligible for endovascular treatment per vascular team evaluation (according to current standards and guidelines) * high risk morphology stenosis (per 2 independent, experienced operators) exclusion criteria: * chronic total occlusion not amenable to re-canalization * stent in the target vessel/lesion * anatomic variants precluding stent implantation * mobile (free-floating) plaque elements in aorta or arteries proximal to target lesion
gene therapy development and validation for huntington's disease fibro tg-hd

Conditions: Huntington Disease

Summary: huntington's disease is a rare and fatal monogenic neurodegenerative disorder whose molecular origin is an expansion of cag triplets within the first exon of the huntingtin gene. although a growing number of emerging therapies are in clinical trials, there are no proven neuroprotective or curative treatments approved by the health authorities, as they have not yet demonstrated any real therapeutic benefit or absence of toxicity. trans-splicing gene therapy is defined as the correction of a mutated endogenous pre-messenger rna by a therapeutic exogenous pre-messenger rna. trans-splicing is a suitable alternative approach, since it is capable of allelic selectivity and replacement of mutated sequences by the wild-type one, criteria that no therapy tested to date meets. this project involves the therapeutic validation of trans-splicing of huntingtin gene transcripts, and will evaluate its therapeutic effects in vitro, into primary fibroblast cell lines derived from skin biopsies of huntington's disease patients.


Eligibility criteria:
inclusion criteria: * 18 ≤ age ≤ 70 years. * signed written, free and informed consent to participate in the study. * patients with a cag≥36 allele (with reduced or full penetrance). penetrance) * people affiliated to or benefiting from a social security scheme. exclusion criteria: * individuals who have participated in a gene therapy trial using aav, aso, mi/si/shrna administration, likely to disrupt expression, splicing of pre-mrnas, mrna splicing, mrna expression/regulation/translation, energy or protein metabolism directly or indirectly linked to the huntingtin gene (htt), its transcripts and proteins. * clinical or paraclinical elements that may suggest a differential diagnosis. * people unable to express their consent. * pregnant, breast-feeding or parturient women * people deprived of liberty by administrative or judicial decision * people under legal protection (curatorship, guardianship).

Keywords: huntington gene therapy trans-splicing fibroblasts
nintedanib for the prevention of radiation pneumonia in unresectable nsclc

Conditions: NSCLC; Nintedanib; Radiation Pneumonitis

Summary: this study is aimed at patients with unresectable nsclc who take nintedanib during sequential radiotherapy to explore the incidence of radiation pneumonitis above grade 2 in the nintedanib combined with radiotherapy mode and observe safety. and will further explore the progression-free survival (pfs) and overall survival (os) of patients treated with nintedanib in combination with radiotherapy and immunotherapy. primary objective: to evaluate the safety of nintedanib combined with sequential radiotherapy in patients with unresectable nsclc and the incidence of radiation pneumonitis above grade 2. secondary objective: to evaluate the changes in lung function, progression-free survival (pfs) and overall survival (os) in patients with unresectable nsclc after nintedanib combined with sequential radiotherapy. patients need to receive induction therapy, chemotherapy and/or immunotherapy for at least one cycle. then they will receive sequential radiotherapy and nintedanib for 6 months. finally, they will receive immunotherapy maintenance therapy for 16 cycles.


Eligibility criteria:
inclusion criteria: * 1) men or women who are over 18 years old (including 18 years old) when signing the informed consent form; * 2) non-small cell lung cancer was confirmed by histology and could not be resected, and egfr/alk driver gene was confirmed negative by gene mutation examination; * 3) at least one measurable lesion with imaging examination (according to recist1.1) is examined by spiral ct or mr, and the length and diameter of the lesion are ≥ 10 mm; * 4) within 3 days before treatment, the score according to ecog is 0 \~ 1; * 5) life expectancy ≥3 months; * 6)the vital organs function well, * 7)the subjects volunteered to join the study and signed the informed consent form, with good compliance and cooperation with the follow-up. exclusion criteria: * 1) complicated with severe respiratory diseases: pulmonary fibrosis, active tuberculosis, etc. * 2)persons with mental disorder, blood system diseases, autoimmune diseases and serious primary diseases of heart, brain, liver and kidney; * 3) hemorrhagic events that require blood transfusion, invasive intervention or hospitalization occur within 3 months before the first administration, or there are bleeding symptoms and need intervention treatment (such as hemoptysis, hematuria and bloody stool), or high-risk factors with bleeding risk (such as tumor surrounding or invading important blood vessels, obvious necrosis or cavity around tumor, esophageal varices, etc.); * 4) thrombosis or embolic diseases, abnormal blood coagulation function and bleeding tendency; * 5) known or suspected to be allergic to the study drug and its auxiliary materials; * 6) the baseline pregnancy test of pregnant and lactating women or fertile women is positive. * 7) according to the researcher's judgment, the subjects have other factors that may lead to the forced termination of this study.
observational to investigate the efficacy of crestor 5mg in reaching ldl-c target goals in patients who are at high risk for a cardiovascular event

Conditions: Hypercholesteremia

Summary: observational study to investigate the use and efficacy of crestor 5 mg in reaching ldl-c target goals in both statin naïve and statin treated primary and secondary prevention patients at high risk for a cardiovascular event.


Eligibility criteria:
inclusion criteria: * the patient has a high risk of a cardiovascular event as defined by the european guidelines. * the patient is statin-naive (i.e. has not used a statin \> 2 months), or is currently treated with atorvastatin, pravastatin or simvastatin. * an ldl-c level is known for the statin-naive patient or for the statin used during visit 1. * it has been decided to start the patient on crestor 5 mg. * the patient is prepared to give permission to the coded data being made available to astrazeneca exclusion criteria: * the patient is known to have complaints of myalgia, myopathy or liver function impairment (including elevated levels of serum transaminases) where there is a causal relationship with the statin treatment. * contraindications for treatment with crestor (see 1 b1 text). * patients with a family history of dyslipidemias, for instance familiar (combined) hypercholesterolemia

Keywords: cholesterol rosuvastatin ldl-c goal observational study primary prevention secondary prevention